Solal Technologies sells supplements that it claims are remedies or prophylactics for a whole range of diseases, including HIV, cancer, hypertension and depression. Naturally, Solal has faced criticism for these claims.

Solal's response has been to instruct their attorneys to send lawyers' letters threatening to sue their critics.

Flashman was a fictional bully and knave. Source: Wikipedia.

I suspect their intention is to intimidate critics and squash criticism of Solal’s numerous unsubstantiated and misleading advertising claims.

Disclosure: I have recently lodged a number of ASASA complaints against unsubstantiated advertising claims made by Solal Technologies and other companies. All the complaints relating to Solal Technologies are still pending.

Untested or false medicine claims in advertisements are ubiquitous in South Africa. Consumers can complain to the Advertising Standards Authority of South Africa (ASASA). But ASASA is overstretched and sometimes takes extraordinarily long to resolve complaints. Also, the advertising code contains several loopholes that charlatans exploit.

Many false and untested claims are in breach of the Medicines Act, but the Law Enforcement Unit (LEU) in the Department of Health does not have sufficient capacity to enforce the act. There is consequently little protection for the public against misleading health claims. It is possible that the Consumer Protection Act might provide more protection against misleading advertising – but it is too early to say.

Against this backdrop of limited law enforcement and industry oversight, it is often left to individual journalists, activists, or members of the public to spot misleading advertisements and report it to ASASA or debunk them in the press or blogs. These people play a crucial role in protecting the public against misinformation and exploitation. It is therefore important that they are encouraged to continue this public service. But one quack company is making a point of trying to discourage them.

Legal threats

Solal Technologies (Pty) Ltd sells supplements that it claims are remedies or prophylactics for a whole range of diseases, including HIV, cancer, hypertension and depression. These claims are often made in expensive adverts on the front pages of large newspapers. For example, the Cape Argus ran one yesterday.

Naturally, Solal has faced criticism for these claims. Harris Steinman has criticised them extensively on his blog, complained to ASASA and reported some of ASASA's findings against Solal on his blog. Roy Jobson has also mentioned Solal on his blog. The Association for Dietetics of South Africa (ADSA) had the temerity to link to one of Steinman's blog entries that criticised Solal.

Solal's response has been to instruct their attorneys to send lawyers' letters threatening to sue Steinman, Jobson and the ADSA. In the letters to Steinman and Jobson, Solal argue that it is defamatory to publish statements arguing that certain of their advertising claims are misleading, unethical, or unsubstantiated. The letters go on to demand that Steinman and Jobson remove all such ‘defamatory’ material from their blogs and refrain from publishing any further ‘defamatory’ statements. Essentially, they are saying “keep quiet, or we’ll sue”. Similarly serious threats were made in a letter to ADSA, but here Solal’s central complaint was that the ADSA newsletter gave more prominent coverage to an ASASA ruling against Solal than it did to a rare ASASA ruling in Solal’s favour.

These defamation threats are clearly spurious. I suspect their intention is to intimidate critics and squash criticism of Solal’s numerous unsubstantiated and misleading advertising claims.

ASASA complaints against Solal's adverts

I am aware of the following complaints that have been lodged with ASASA against Solal – with ASASA mostly ruling against Solal:

The South African Sugar Association lodged a complaint about an advertisement for Solal’s Naturally Sweet product. The advertisement claimed various harmful effects of sugar. The complaint was upheld by ASASA in December 2009. Solal appealed the ruling and was turned down in February 2010, but a second appeal was successful in May 2010. The matter is now awaiting arbitration.

Kevin Charleston also lodged a complaint against Solal's Claim that one of their vitamin D products can prevent cancer. In February 2011 the complaint was upheld.

I recently lodged two complaints against Solal. Both matters are still before ASASA. A further complaint I submitted on behalf of the Treatment Action Campaign is also still awaiting a ruling.

The vitamin D example above illustrates very well the lack of substantiation common to many Solal advertising claims and warrants a closer look.

On 5 May 2010 Solal ran an advertisement on the front page of Die Burger newspaper. English versions of the advert were run in other publications. It claimed that vitamin D was as effective as the flu vaccine in preventing influenza.

First, the 42% relative risk reduction over placebo reported in the study was only found in specific sub-groups of Japanese ten-year-olds. There is no basis for generalising to the average health person based on such a small and unique sample.

Second, and even more crucially, the study only compares vitamin D supplementation with placebo and not with the flu vaccine. It is therefore unclear where Solal get their comparison from. Even if they did cite studies on vaccine efficacy, it would make no sense to compare those much larger trials with this one small trial in Japanese school children.

The claim that vitamin D supplementation is as effective as the flu vaccine is therefore unsubstantiated and misleading. Either the authors of the advertisement have a very poor understanding of how medical evidence works or they are purposefully misrepresenting findings to help sell vitamin D supplements. The same could be said for many of their other advertising claims.

Solal’s questionable expert witnesses

In response to complaints before ASASA, Solal has twice called expert witnesses who appear to question the link between HIV and AIDS.

In the vitamin D/flu vaccine case mentioned above, Solal presented expert evidence from Dr Donald Miller. In their ruling, the ASA wrote “Doctor Miller appears to support the notion that HIV does not cause AIDS”. They also had doubts as to his independence since Miller encouraged readers of his blog to purchase supplements from his wife’s website. The ASA discarded Miller’s expert testimony.

In their first appeal against the ASA ruling on the Naturally Sweet advertisement, Solal presented expert testimony from Dr Neil Burman. Burman is the CEO and “managing physician” of a supplement company called Healthspan Life. Interestingly, Dr Craige Golding of Solal is listed under Healthspan Life’s leadership. The Healthspan Life blog at one point describes AIDS as “a disease which is in fact a sociological problem of nutritional immunodeficiency upon which is superimposed sexual violence as in rape or voluntary recklessness usually against (usually) innocent partners” (sic). Unsurprisingly, the ASA ruled that Burman was also not a credible independent expert.

In response to one of Kevin Charleston's ASASA complaints as well as to one of my complaints, Solal, instead of verifying the accuracy of their claims, submitted an absurd defence to the ASA based on attacking us. They claimed, for example, that “stylometric tests” showed that there was no significant difference between the styles of Charleston, Steinman and myself. Now, I have had some contact with Harris Steinman, but neither Harris nor I even knew who Charleston was at the time. In any case, even if we sat in the same room together working out ways to annoy Solal (which we don't), it would be irrelevant. ASASA rejected this nonsense. Ironically Charleston's ASASA victory resulted in him making contact with us and consequently writing for Quackdown.

Taken together, the legal threats against Solal’s critics, the ASASA rulings against Solal, Solal’s many unsubstantiated claims and the questionable experts Solal has called before ASASA paints a very worrying picture. Consumers have a right to be accurately informed about the products they buy. Unfortunately, it appears that Solal is doing everything in its power to prevent this right from being realised in relation to their products.

Thank you to Faizel Slamang for research on Solal that has been used in this article.

Comments in chronological order
(60 comments)

Thank you for not backing down in the face of Solal's legal bullying. Keep up the good work!!

Roy Jobson
wrote on 30 March 2011
at 8:01 a.m.:

I can confirm that I did indeed receive such a letter from the lawyers representing Solal. I deny all the allegations made by Solal. I will not be intimidated from telling the truth, or helping to expose misrepresentations of product claims - whether made by Solal or others. I am not in the employ of the pharmaceutical industry.

Harris
wrote on 30 March 2011
at 11:05 a.m.:

My response would be similar to that of Prof Roy Jobson's, above.

I do not know if you are aware that Solal’s magazine, Health Intelligence, has a Medical Advisory Board – doctors and health professionals from around the world. A local one is Dr Arien van der Merwe. Her “expert opinion” was used to support the (false) claims that Biobust will make your breast fuller, firmer and larger (Advertising Standards Authority (ASA) complaint). She also advocated the use of a banned substance, Kava, on her website for a while after it was banned, and the most damning, that she was a Fellow of the Royal College of Alternative Medicine (FRCAM) – a “Royal College” that was not a Royal College actually and that she was the “Academic Dean” of! She no longer lists this "qualification" on her website.

Part 1 of 3
(This blog only allows 3000 characters per response, so our response is in 3 parts).

At no point has SOLAL Technologies ever claimed to offer a prophylactic (preventative) or treatment for HIV or AIDS. Such a claim does not appear on any of our labels. We merely offer a protocol of supplements that are useful for HIV/AIDS SUPPORT. Low’s statement to this effect is simply false. These products do not claim to prevent or treat HIV/AIDS, nor do they claim to reduce the risk of transmission. They are merely supportive. For example, probiotics and glutamine help to reduce the intestinal ulceration and poor nutrient absorption that is common in AIDS patients. We do NOT, nor have we EVER, claimed that supplements can cure of prevent HIV or AIDS, or that they will reduce the transmission of HIV. Furthermore we do NOT advocate that a person discontinue antiretroviral medication in favour of supplements. Nor do we suggest that supplements should EVER be used in place of antiretrovirals. In fact we caution against the use of certain supplements when taking antiretrovirals due to the possibility that certain supplements can activate liver enzymes that could reduce the levels of antiretroviral medicines to ineffective levels.

With regards to cancer – once again, we DO NOT offer cures for cancer. We offer natural medicines that REDUCE RISK of developing cancer. These include green tea, broccoli extracts, curcumin, vitamin D3 and other cancer risk-reducers for which there is ample scientific evidence.

With regards to products for hypertension and depression – we do offer natural medicines that help these conditions, BUT never as a substitute for conventional medicines. Furthermore, if a patient is already on a prescription medicine for hypertension or depression, we always advise that they do not discontinue these medicines unless their doctor believes that they should.

Marcus Low has not been honest about the real reason that we are taking legal action against Harris Steinman, Roy Jobson et al. The reason they give is that we want to stifle healthy criticism. This is untrue. The real reason is because they have made defamatory and untrue statements about our pharmacist Brent Murphy, and against our medical director Dr Craige Golding, as well as accusing us of trading illegally. We believe that this vigilantism is motivated by a fanatical anti natural medicine bias and lack of understanding or wanting to understand the different paradigms of medicine practised both locally and internationally. Further, none of these critics are trained in any paradigm of natural medicine or alternate medicine and speak from a position of weakness and bias.

Part 2 of 3 (This blog only allows 3000 characters per response, so our response is in 3 parts).

Solal does not take legal action against our critics, we take legal action against those who act unlawfully by making untrue and defamatory statements. Therefore it is Solal’s intention to STOP people from making untrue and defamatory claims under the guise of debate and criticism. It is our right to legal protection from unlawful behaviour. South Africa is governed by the rule of law and not by the rule of bloggers on Quackdown.

Below are examples of distortive, misleading and dishonest statements made by Low:

1) The Sugar Association lodged a complaint with the ASA against our claim that excess sugar consumption can cause cancer and a number of other serious medical conditions. In our first response to the ASA, they found our expert was not sufficiently independent and made a ruling as such. This ruling was published prominently by ADSA in their newsletter. When this ASA ruling was subsequently overturned by the ASA, ADSA did not publish this fact. When we brought this fact to ADSA’s attention, they published NOT very prominently various ambiguous comments regarding the ruling which most ADSA members would not understand as completely reversing the initial ruling. The claim that sugar excess can cause cancer was substantiated and ADSA members are still unaware of this due to their association misleading their members as to the true nature of the ASA ruling. The attempt of the Sugar Association to hide the dangers of sugar excess is scandalous especially in South Africa, where according to the World Health Organisation, we consume excessive sugar which contributes to a host of chronic diseases that cause premature death. This matter is NOT awaiting arbitration as Marcus Low has dishonestly stated but is final and NO arbitration in this matter is contemplated by the ASA.
2) The complaint that Harris Steinman lodged about our Health Shake referred to an advert that was erroneously swapped by the newspaper itself, who used the incorrect material and therefore not withdrawn as Low misleadingly suggests.
3) Regarding the Charleston and Laithwaite ASA complaints, and in fact all other complaints against SOLAL: The ASA have undertaken to suspended all proceedings against Solal as they are concerned that they do not have the legal power to rule on such matters. In fact it may be that the few ASA rulings against Solal are fatally flawed.

Part 3 of 3 (This blog only allows 3000 characters per response, so our response is in 3 parts).

4) With regards to Vitamin D, Solal Technologies has never advocated the use of Vitamin D instead of the flu vaccine. In fact, in our advertising and marketing material we have expressed the importance of using both. With regards to Low’s criticism of our statement that Vitamin D is as effective as a flu vaccine, our stance is based on much more than merely the Japanese study that he refers to. For example of such studies see: http://www.vitamindcouncil.org/science/research/vitamin-d-and-influenza.shtml

Furthermore, there is recent and compelling evidence published by the Cochrane Scientific Review, the most trusted source of medical information in the world, that the flu vaccine is ineffective for young children and the elderly, and is only marginally effective (1-2%) for other age groups. This evidence can be reviewed here: http://www.solaltech.com/cochraneflu/CochraneFlu.pdf

5) Solal’s medical advisor, Dr Golding has no affiliation with Dr Burman or with the Healthspan website, and we had requested that his name be removed from this website when we became aware of this many months ago.

6) With regards to the stylometry tests, which are tests used to determine who the true author of a particular document is: These were included in our response to the ASA as evidence suggesting that Harris Steinman has surreptitiously assisted others in lodging complaints or has lodged complaints in other people’s names which is not permitted in terms of the ASA Code.

The MCC (Medicine Control Council) sets the standards in South Africa for medicines, not Roy Jobson and Harris Steinman. These two individuals set their own standards by making up their own rules of what is required to substantiate a claim. The self serving “self imposed” standards of evidence called for by Steinman and Jobson are inappropriate as there is ample evidence in published peer reviewed medical journals to support the claims that Solal Technologies makes.

TO CONCLUDE:
Solal Technologies would like to put on record that we do believe that HIV causes AIDS, that we do believe that ARV’s are essential for people living with HIV/AIDS. We do not believe that nutritional supplementation can treat, prevent, cure or stop the transmission of HIV/AIDS. Furthermore, we do not believe that Vitamin D should be used as a substitute for the flu vaccine. Vitamin D should however be used by everyone who is given the flu vaccine.

Im not sure what you could be referring to. Of course we have references and provide these. And they are freely available to you via pubmed and other sources too.

Regards

Brent.

Kevin Charleston
wrote on 31 March 2011
at 12:40 a.m.:

Brent,
I have never met Harris or Marcus. I have exchanged one email with Harris - this year, subsequent to my complaints. There is no limit on valid complaints submitted to the ASA - no-one needs to hide. Even if the complaints were 'surreptitiously' aided - the complaints were still valid and were upheld by the ASA.

Why don't you link to the actual review on the Cochrane site? http://www2.cochrane.org/reviews/en/ab004876.html
does not say vaccines are ineffective - merely that the studies are of not good enough quality to give any guidance.

http://www2.cochrane.org/reviews/en/ab004879.html suggests that vaccines are not considered effective for children under the age of two. 82% efficacy over placebo for children older than two.

The advert that read "Vitamin D is as effective as a vaccine" in no way reflects "the importance of using both". Perhaps you want to review a copy of it before making such statements? I have a copy to which you can refer if you have lost yours.

“Please note that SOLAL Technologies is NOT suggesting that you do not get a flu vaccination. Flu vaccinations are very important for people who are at increased risk of exposure to the virus, such as medical workers and the elderly. What we ARE saying, is that no matter whether you choose to get a flu vaccination or not, supplementing with vitamin D3 throughout winter is extremely important.”

Following the May 2010 advert, we ran this statement in newspapers in Sept 2010:
“NOTE: SOLAL Technologies does not discourage flu vaccination. In fact, there is evidence that vitamin D enhances the effectiveness of flu vaccinations. SOLAL Technologies believes the ideal is to use both the flu vaccine and vitamin D.”

So I wish to emphasise: We have NEVER advocated the use of vitamin D INSTEAD of the flu vaccine.

With regards the 2 Cochrane review links you posted: Are you saying that the absence of evidence showing effectiveness of flu vaccines is evidence that they are in fact effective? If you are then you are going against all you appear to stand for when complaining to the ASA, where you insist on substantiation.

The review states the following clearly:
“Due to the poor quality of the available evidence, any conclusions regarding the effects of influenza vaccines for people aged 65 years or older cannot be drawn.”
“The available evidence is of poor quality and provides no guidance regarding the safety, efficacy or effectiveness of influenza vaccines for people aged 65 years or older.”
“In children under the age of two, the efficacy of inactivated vaccine was similar to placebo.”

Where is the substantiation in these two age groups? There is none.

According to the review there is no evidence of efficacy for the flu vaccine for the very young (under 2 years of age) or the old (over 65 years of age).
Now, before you get concerned, this lack of proof of efficacy of flu vaccines in these 2 age groups is NOT something SOLAL has been advertising to the public. In fact we have been recommending combining the flu vaccine with vitamin D because it is prudent to do so.

However I do bring it up the cochraine review in academic forums and debates when challenged.

Regards

Brent Murphy – B.Pharm (Rhodes), MPS
SOLAL Technologies Pty Ltd

Kevin Charleston
wrote on 31 March 2011
at 7:57 a.m.:

Brent, that is NOT the advert that appeared in the Star in April 2010.

I have forwarded a copy of that advert to the webmaster - perhaps he can make that available here so everyone can see that you are talking out of your hat.

The Cochrane review confirms there is evidence supporting vaccine of children over the age of two, but not for younger. In the elderly the study says nothing. I don't take it to mean the absence of evidence means that vaccines are effective - I take that to mean precisely nothing. What I do not take is that it means that vaccines are ineffective - or that Vitamin D is better. This is not something that supports your argument in any way. Since those studies don't refer to Vitamin D at all there is no reason to consider them as supporting you in any way.

Are you really suggesting that Vitamin D is helpful wrt influenza to those younger than two or older than 65 - merely because there are no studies that say a vaccine works in those groups?

The single advert in April 2010 that you refer to makes no mention of using vitamin D instead of a flu vaccine or otherwise. It makes no statement in this regard either way. So please don't put words in my mouth that I have ever advocated using vitamin D instead of the flu vaccine. I have not.

I do concede that the initial advert you are referring to could be misinterpreted by the reader as meaning that vitamin D should be used instead of the flu vaccine (which we never said and have never believed). Therefore all future adverts (May 2010 onwards) included the statement that SOLAL suggests that BOTH the vaccine AND vitamin D are used together, as my links to the advert proves in my previous post.

Regarding the Cochrane reviews: You say the elderly cochrane review says nothing yet this is not true. The elderly study says:
“Due to the poor quality of the available evidence, any conclusions regarding the effects of influenza vaccines for people aged 65 years or older cannot be drawn.”
and
“The available evidence is of poor quality and provides no guidance regarding the safety, efficacy or effectiveness of influenza vaccines for people aged 65 years or older.”

In other words what its saying is: There is no evidence of effectiveness in the over 65’s. That’s powerful stuff, especially when coming from Cochrane.

Notwithstanding this, SOLAL still maintains it is better to be safe than sorry, and therefore to use the flu vaccine in the over 65s (in addition to taking vitamin D).

The reason I believe vitamin D is useful in all ages as part of an influenza prevention protocol (and NOT INSTEAD OF THE VACCINE), including the over 65s, is not at all based on the Cochrane review but independent and copious research on vitamin D itself. The link to much of this research is given in my initial post above.

Regards

Brent

Brent Murphy - B.Pharm (Rhodes), MPS
Pharmacist
SOLAL Technologies.

Nathan Geffen
wrote on 31 March 2011
at 9:15 a.m.:

In fact the Solal advert in question has the heading "Vitamin D is as effective as a vaccine".

No Brent, you still don't get it.
The Cochrane review says that "any conclusions ... cannot be drawn". That means the quality of the data before them is not sufficient. It says a lot about the evidence - but nothing about a conclusion. To use it to support that there is "no effectiveness" is outrageous. Lack of evidence because of poor studies does not mean the vaccine is ineffective - it means we just can't say anything.

My question to you now is this: you concede that the original advert was misleading, so you changed it. Would you have changed it without a challenge to the ASA?

From what you have written here it appears you no longer claim "Vitamin D is as effective as a vaccine" - so why was it used in the first place?

I believe that without mechanisms like the ASA, and people in the street pointing out the absurdity of claims like this, companies like yours will try to dupe people into believing anything.

Brent, for my edification, please then provide those links. (I've looked at your website, but it made my eyes bleed. I couldn't find a research page providing justifications for your various positions by listing all those studies. Oh, and I'm not an idiot. If you say study X shows "thou shalt drink vitamin C in megadoses" and it doesn't actually say that, I'll notice).

Harris
wrote on 31 March 2011
at 11:03 a.m.:

I will be putting up a detailed response to Solal's absurb and highly misleading response to Marcus Low's letter in due course.

For now, want to post a better copy of the "Vitamin D is as effective as vaccine" advert that appeared. The claims and inferences are self evident. http://www.camcheck.co.za/wp-content/uploads/2010/05/vit-d-better-than-vaccine_s.jpg

Nathan Geffen
wrote on 31 March 2011
at 11:15 a.m.:

Brent, I am astonished at your line of argument.

Neither Kevin nor Marcus have stated above that you advocate using Vitamin D instead of the flu vaccine.

Both of them have written, correctly, that Solal's advert (the one I link to above) claims that Vitamin D is as effective as vaccine. It is the heading of the advert!

The evidence simply does not support this claim. That alone supports the key contention here: Solal runs misleading adverts.

But furthermore many people would reasonably conclude from your advert I have linked to above that they could use Vitamin D instead of vaccine. Many people will have to make a choice, "Do I spend my hard-earned money on Solal's Vitamin D supplements or a flu vaccine?" Your advert misleads them into choosing your product over a flu vaccine. So Kevin is correct to have written, "The advert that read "Vitamin D is as effective as a vaccine" in no way reflects "the importance of using both".

Having said that, the current best evidence does not support using both for the prevention of flu. It only supports using the vaccine.

Nathan Geffen
wrote on 31 March 2011
at 11:38 a.m.:

Vitamin D side-effects

Solal states, "Vitamin D is extremely safe. There are virtually no side effects from people taking vitamin D supplements, even at seemingly high doses such as 2000 IU per day (five times the current South African RDA)"

I have compiled some documents for you to view and have placed them in the following folder:

http://www.solaltech.com/brent/michael

I have included a number of documents including evidence of vitamin D’s effectiveness in helping to reduce the risk of influenza, the Cochrane review on effectivenss of the vaccine, evidence that SOLAL has been recommending combining vitamin D and the flu shot together (not vitamin D instead of the vaccine), vitamin D blood levels pathology lab results of South African adults and children(I have anonymised the data by removing the names of patients).

I have also included safety data on vitamin D in my link above: According to the National Institute of Medicine in the USA, advisor to the US government, Vitamin D safe at doses up to 4000IU daily, twice what SOLAL claims is safe (Nathan your links don’t mention anything about safe dose of vitamin D).

Regards

Brent

Colin Levin
wrote on 31 March 2011
at 12:57 p.m.:

Nathan, Your insistance that 2000iu's of Vitamin D is not safe is laughable, misleading, potentially dangerous and therefore shows your absolute ignorance. The links you refer to make NO reference to safe Vitamin D dosages, they merely warn of overdose. Well overdosing on anything is not advised. Quite frankly your comments are not surprising given that you have no medical education or clinical experience. Brent, a pharmacist has provided you with appropriate safety data. He also does not profer IT advice.

Harris
wrote on 31 March 2011
at 1:30 p.m.:

Colin makes the fatal mistake of assuming that Brent must be correct - in particular because he is a pharmacist - therefore everyone else is wrong. The fact that Brent's / Solal's "substantiation" is often contrary to expert reviews of complementary medicines, such as Natural Medicines Comprehensive Database, demonstrates this problem. It may be that as Colin has no medical education or clinical experience, that he is unable to appreciate when Brent/Solal is simply completely wrong. That Solal's claims are often out of sync with all major scientific bodies is simply explained that they know better!

[HTML_REMOVED]Here[HTML_REMOVED] is one one example of how bizarre their scientific interpretation can be.

Harris
wrote on 31 March 2011
at 1:33 p.m.:

Colin makes the fatal mistake of assuming that Brent must be correct - in particular because he is a pharmacist - therefore everyone else is wrong. The fact that Brent's / Solal's "substantiation" is often contrary to expert reviews of complementary medicines, such as Natural Medicines Comprehensive Database, demonstrates this problem. It may be that as Colin has no medical education or clinical experience, that he is unable to appreciate when Brent/Solal is simply completely wrong. That Solal's claims are often out of sync with all major scientific bodies is simply explained that they know better!

Here is one one example of how bizarre their scientific interpretation can be: http://www.camcheck.co.za/solal-too-much-sugar-claim-no-2/

Kevin Charleston
wrote on 31 March 2011
at 2:09 p.m.:

Is that Colin the "Financial and Legal Director" at SolalTech? A bit like the pot calling the kettle black then? It appears he also has no medical or clinical experience.

You state. "Well overdosing on anything is not advised." Too true. Pity the Solal advert doesn't provide any such caution, which is shocking when advertising a medicine (and in the ad vitamin D falls into the Medicines Act definition of medicine). I would be horrified if I saw an advert claiming that "ARVs are extremely safe. There are virtually no side effects from people taking ARVs even at seemingly high doses."

At what dose can vitamin D cause side-effects?

For vitamin D, an increased risk of kidney stones have been shown in a study of post-menopausal women taking 400IU of vitamin D and 1000mg of calcium daily. Ref

Now perhaps it was the calcium, perhaps not. We just don't know. But it is irresponsible and in contradiction of available evidence to claim that vitamin D at 2000IU is extremely safe and has virtually no side effects. It might be beneficial; it might even be that the benefits outweigh the risks, but you cannot claim that it extremely safe and has virtually no side effects. (Incidentally, kidney stones are truly awful.)

Furthermore, the advert promotes Vitamin D "at any age" without explaining that >1500IU/day for infants is dangerous. ref, table 4

Some people get too little vitamin D from food and sun. But some don't. When you take into account that a small group of people get substantial vitamin D intake from food and sunlight, it's plausible that 2000IUs per day in a supplement alone may shift that group of people into dangerous territory.

Colin Levin
wrote on 31 March 2011
at 2:34 p.m.:

Another generalised comment Harris. You seem to like to diverting matters from the issue to another issue in a generalised manner. Harris why dont you also pin your colours to the mast and state whether you believe 2000iu's of vitamin D is unsafe or not? I may not be a pharmacist or doctor but that is why I emoploy them. I have not commented on the safety of Vit D, Brent our pharmacist has done so. By the way you have no formal education in natural medicine neither do you have any clinical experience in using CAMS. All your citicisms are purely academic. Nathan makes the fatal mistake of assuming that Harris must be correct - in particular because he is a doctor - therefore everyone else is wrong. The fact that Harris's "criticism" is often contrary to expert practitioners of complementary medicines, demonstrates this problem. It may be that as Nathan has no medical education or clinical experience, that he is unable to appreciate when he or Kevin is simply completely wrong. That Nathan's allegation that 2000 iu of Vit D is unsafe is often out of sync with all major scientific bodies is simply explained that they know better!

I have used your words that you have used to demonstare the very same double standards that you, Nathan and Kevin employ and dont seem to appreciate. You need to hold everyone ie Nathan, Kevin up to the same standard that you want to hold others including ourselves to.

Since these are tablets advertsied to adults, in a newspaper, I believe the reasonable reader would realise that the Vitamin D safety statment of 2000IU daily was not referring to babies under 12 months old.

Babies and toddlers older than 12 months can safely take 2500IU.

And to be clear we were NOT telling people to take this amount in a supplement. We were merely informing them that vitamin D is safe at levels of 2000IU. This is especially important bearing in mind the apparent low vitamin D levels of South Africans.

METHODS: A total of 884 HIV-infected pregnant women who were participating in a vitamin supplementation trial in Tanzania were monitored to assess pregnancy outcomes and child mortality. The association of these outcomes with maternal vitamin D status at enrollment was examined in an observational analysis.

RESULTS: No association was observed between maternal vitamin D status and adverse pregnancy outcomes, including low birth weight and preterm birth. In multivariate models, a low maternal vitamin D level (<32 ng/mL) was associated with a 50% higher risk (95% confidence interval [CI], 2%-120%) of MTCT of HIV at 6 weeks, a 2-fold higher risk of MTCT of HIV through breast-feeding among children who were HIV uninfected at 6 weeks (95% CI, 1.08-3.82), and a 46% higher overall risk of HIV infection (95% CI, 11%-91%). Children born to women with a low vitamin D level had a 61% higher risk of dying during follow-up (95% CI, 25%-107%).

CONCLUSIONS: If found to be efficacious in randomized trials, vitamin D supplementation could prove to be an inexpensive method of reducing the burden of HIV infection and death among children, particularly in resource-limited settings.

.....maybe its time there were randomised trials performed on vitamin D in this regard in SA?

Harris
wrote on 31 March 2011
at 3:15 p.m.:

No Colin, not generalised! Specific!

There is NO evidence that Solal are "expert practitioners of complementary medicines" - it is a self-anointed title. Certainly none of your practitioners hold a title in this field that is recognised by the HPCSA or College of Medicine or any other recognised accredited body. And embarrassingly for you, Brent's only experience is from studying texts like most of us do - or is dispensing of meds make him a recognised expert?

And I have not commented on the safety of Vitamin D because that was not an issue I ever addressed in reference to this specific product - my main thrust that I have not deviated from is that the claims that was made, or inferences if you prefer, were wrong! Adding a disclaimer after the fact does NOT alter this contention.

And the most embarrassing part of your argument that I am sure that readers of this blog has noted, is that Solal simply keeps on missing the point: evidence based medicine is not based on anecdotal reports but on universally accepted scientific principles, as applied by myself, Nathan, Marcus, the experts at Natural Medicines Complementary Database, and practically every health professional except some purveyors of CAMS. Solal expects consumers to accept that a different form of evidence is applicable to evaluating CAMS.

And yes, one does not have to be dispensing CAMS or practice medicine to develop remarkable skills in logic, deconstruction of studies, and the application of sound scientific principles! If your contention was true, then the MCC have no right to evaluate medicines! And oh, what percentage of your therapeutic claiming products are registered with the MCC which requires proof of efficacy and safety? I guess less than 20%?

I notice a deafening silence on the critisism of your Sugar mark II claims, where the study was conducted in male-only weanling carbohydrate-sensitive rats (yes, the rats were rendered carbohydrate-sensitive first), and results of this study extrapolated to humans! I am making this point to emphasise that a similar process was followed with the "Vit D is as effective as vaccine" claim, which could have had the effect of people replacing one with the one.

Nathan Geffen
wrote on 31 March 2011
at 3:22 p.m.:

Brent, I would have no problem with micronutrient trials approved by a recognised ethics committee and the MCC.

What is problematic is retailers advertising micronutrient supplementation, either generally or for specific conditions, before there is adequate evidence to support those contentions.

And even when there is evidence, the advertising claims are often vastly exaggerated. Solal exemplifies this unethical advertising.

Here is the recently updated Cochrane Review on micronutrient supplementation for people with HIV:

Colin Levin
wrote on 31 March 2011
at 3:28 p.m.:

Nathan, perhaps if you applied the very logic you speak of and since you have "cherry picked" one study you should also advise your readers that most kidney stones are in fact made out of calcium not Vit D. The form of calcium that was used in this study was calcium carbonate. Calcium carbonate is used as a filler in many medicines. Martindale a relatively conservative pharmacopia (not Solal) confirms that 2000iu's of Vit D daily is safe, perhaps you and Kevin should take your complaint to Martindale too. Remember I am not commenting on the safety of Vit D, our pharmacist has. However you both have catagorically stated that it is untrue to state that 2000iu's of Vit D is safe. You both need to substantiate your statements using the same criteria that you expect all others you have been critical of to do. Lets see your "robust" evidence? The absence of your evidence will be nothing short of hypocrisy.

I fully agree with this cochrane review you have linked to. And I was not being facetious that a few randomised trials should be performed here. I think there are other supplements such as probiotics and glutamine which have been shown to reduce muscle wasting and diarrhoea in people living with HIV/AIDS. And then there is the adrenal hormone DHEA that appears to improve quality of life scores and reduce muscle wasting.

Abstract
AIM: To evaluate the long term effect of yogurt supplemented with Lactobacillus rhamnosus Fiti on the immune function (CD4 count) of people living with

HIV/AIDS.
BACKGROUND: Gastrointestinal infections and the leakage of microbial products from the gut have a profound impact on the deterioration of the immune system among people living with HIV/AIDS. Among persons not infected with the virus, probiotics can prevent gastrointestinal infections and restore an effective gut barrier, suggesting they might have a beneficial effect on the immune function of people living with HIV/AIDS.
STUDY: We carried out an observational retrospective study over a period of 3 years, with longitudinal comparison of the CD4 count within participants (n=68) before and during probiotic yogurt consumption, and compared with a control group of participants not consuming the yogurt (n=82).
RESULTS: Among the yogurt consumers before use and the nonconsumers, an average increase in CD4 count was seen of 0.13 cells/μL/day (95% CI; 0.07-0.20, P=<0.001). After commencing consumption, yogurt consumers experienced an additional increase of 0.28 cells/μL/day (95% CI; 0.10-0.46, P=0.003). When adjusting for length of time using antiretroviral medication, the additional increase explained by yogurt consumption remained 0.17 cells/μL/day (95% CI; 0.01-0.34, P=0.04). Treatment with antiretroviral medication was associated with an increase of 0.27 cells/μL/day (95% CI; 0.17-0.38, P=<0.001).
CONCLUSION: The introduction of probiotic yogurt, made by local women in a low-income community in Tanzania, was significantly associated with an increase in CD4 count among consumers living with HIV.

Nathan Geffen
wrote on 31 March 2011
at 3:48 p.m.:

Colin, you clearly don't understand how these things work.

In medicine, the burden of proving safety falls on the medicine supplier/manufacturer. Your ad claimed that vitamin D is extremely safe and has virtually no side-effects even at 2000IU.

I cited evidence that suggests this might not be true, even at much much lower doses than 2000IU. As I wrote above, it is possible the calcium was at fault in the one trial, but it is VERY complicated; kidney stones is a field in which there is much that is unknown. It is possible the vitamin D is also involved, or even primarily involved. We just don't know. A responsible company therefore would not make the claim that Vitamin D has no side effects.

This is not just the opinion of a lowly uneducated computer programmer. It is the opinion of the FDA, the IOM and others. Here's an example.

The point is if you sell a medicine, DON'T claim that it has virtually no side effects.

Health Risks from Excessive Vitamin D

Vitamin D toxicity can cause non-specific symptoms such as anorexia, weight loss, polyuria, and heart arrhythmias. More seriously, it can also raise blood levels of calcium which leads to vascular and tissue calcification, with subsequent damage to the heart, blood vessels, and kidneys [1].

The use of supplements of both calcium (1,000 mg/day) and vitamin D (400 IU) by
postmenopausal women was associated with a 17% increase in the risk of
kidney stones over 7 years in the Women's Health Initiative [65]. A serum
25(OH)D concentration consistently >500 nmol/L (>200 ng/mL) is considered to
be potentially toxic [5].

[My italics for Colin's sake.]

etc.

I suggest reading the whole thing. The comments section is not the place to reproduce it in its entirety.

Kevin Charleston
wrote on 31 March 2011
at 10:33 p.m.:

Colin.
Where exactly have I written that "it is untrue to state that 2000iu's of Vit D is safe.". You make the claim that I have categorically stated this?

What, specifically, have I written that is either wrong or employs double standards? Which you also claim?

I assume that by 'Martindale' you mean "The Complete Drug Reference" and not "Martindale's Pharmacy"? I have no need to buy the reference work or a subscription to it. Why should I?
'Martindale' is not advertising that "Vitamin D is extremely safe and that there are virtually no side-effects from using it". Your organisation IS - in the same advert that claimed that claims "Vitamin D is as effective as a vaccine". I still don't have an answer to my questions to Brent in that regard. Perhaps the "Financial and Legal Director" with strong opinions about who may or may not understand medical studies can give me his answers to the same questions then?

Please note the following also: We inserted this statement in our adverts BEFORE we received your complaint: “NOTE: SOLAL Technologies does not discourage flu vaccination. In fact, there is evidence that vitamin D enhances the effectiveness of flu vaccinations. SOLAL Technologies believes the ideal is to use both the flu vaccine and vitamin D.”

So the addition was not in response to your complaint.

The reason we did so, I have already explained in my posting made yesterday at 9.02am (see above), where I said:
"I do concede that the initial advert you are referring to could be misinterpreted by the reader as meaning that vitamin D should be used instead of the flu vaccine (which we never said and have never believed). Therefore all future adverts (May 2010 onwards) included the statement that SOLAL suggests that BOTH the vaccine AND vitamin D are used together, as my links to the advert proves in my previous post."

Finally, I need to clarify something to all, let’s say paracetamol is as effective ibuprofen at treating a headache, it does not necessarily mean that it should be used INSTEAD of ibuprofen. The ideal is to use them together because their mechanisms of action (pharmacologies) are different and complement each other. The same applied to vaccines and vitamin D. Without vitamin D the vaccine is less effective and their pharmacologies are COMPLETELY different. They should be used together, hence the clarification we made in all subsequent adverts.

This is what our advert said:
"Vitamin D is extremely safe. There are virtually no negative side effects from people taking vitamin D supplements EVEN AT SEEMINGLY HIGH DOSES SUCH AS 2000IU PER DAY".
That is what you objected to as untrue, and 2000IU was the "high dose" you called poisonous.

Regards

Brent

Nathan Geffen
wrote on 1 April 2011
at 10:59 a.m.:

Kevin wrote:
This is what our advert said: "Vitamin D is extremely safe. There are virtually no negative side effects from people taking vitamin D supplements EVEN AT SEEMINGLY HIGH DOSES SUCH AS 2000IU PER DAY".

As I've explained above this is an unsubstantiated and irresponsible statement. There is evidence that indicates that vitamin D might cause side-effects at much lower doses.

Kevin Charleston
wrote on 1 April 2011
at 11:04 a.m.:

Brent, I am intrigued. The documents you provided: "vitamin D blood levels pathology lab results of South African adults and children". One document states "Recommendations were made that blood concentrations of vitamin D should be at least 20 nanograms/mL". A simple analysis of the data you have provided suggests that 187 out of the 724 data points are at or below 20 n/mL. I.e. around 25% are below the recommended level.
I note that less than 10% are at the level (below 15 n/mL) deemed by the NIH to be 'deficient'.

Where do you get the figures to support the statement in your advert (even the one you have changed) that "90% of South Africans tested at the Integrative Medical Centre in Bryanston last year were deficient in vitamin D"

There is no good evidence that vitamin D below 2000IU is unsafe; not vitamin D PLUS calcium causing kidney stones.... cos that like saying that turkey breast is unsafe because it causes gout.

Vitamin D is exceptionally safe at doses of 2000IU (its actually safe in much higher doses). All leading medical authorities agree.

I am somewhat disillusioned with you at the moment because you seem to be arguing merely for arguments sake. It’s like this is some sort of school debate where its all about winning for the sake of winning, not to actually listen and hear.

Nathan I can’t force you to see the facts. Only you can elect to do that. Maybe you are so used to fighting just causes (which I salute and commend you on by the way), that your knee-jerk reaction is to fight even when your fight is unjust and persecutory.

I can’t participate in a win-at-all costs debate. I think I have pretty much said all I can in this regard.

Hi Kevin
With regards to our statement that “90% of South Africans tested at the integrative medical centre were deficient in vitamin D”:

These were in patients with two or more of the following co-morbidities: osteoporosis, heart disease, hypertension, an autoimmune disease, cancer, depression, chronic fatigue or chronic pain.

The reference level we used as a cut off was 50ng/ml, based on recommendations from the vitamin D council, here: http://www.vitamindcouncil.org/vdds.shtml where they state:

“We propose Vitamin D Deficiency Syndrome (VDDS) exists when 25(OH)D levels of less than 50 ng/mL are found in patients with two or more of the following conditions: osteoporosis, heart disease, hypertension, autoimmune diseases, certain cancers, depression, chronic fatigue, or chronic pain.”

However, due to criticism of bias against the vitamin D council, in subsequent advertising (last year) we changed the “90%” to “80%”, since a review published in alternative medicine review in 2005 stated that vitamin D sufficiency can only be said to exist (in healthy people) when levels of vitamin D are 33ng or greater.

The data we supplied of people in Bryanston showed that 81.8% of people had below 33ng/ml of vitamin D.

See: Benefits and requirements of vitamin D for optimal health: a review.
Located here: http://www.ncbi.nlm.nih.gov/pubmed/15989379

Extracts:

“The current vitamin D requirements in the United States are based on protection against bone diseases. These guidelines are being revised upward in light of new findings, especially for soft-tissue health.”

“The consensus of scientific understanding appears to be that vitamin D deficiency is reached for serum 25-hydroxyvitamin D (25OHD) levels less than 20 ng/mL (50 nmol/L), insufficiency in the range from 20-32 ng/mL, and sufficiency in the range from 33-80 ng/mL, with normal in sunny countries 54-90 ng/mL, and excess greater than 100 ng/mL.”

Regards

Brent

Brent Murphy - B.Pharm (Rhodes), MPS
Pharmacist
SOLAL Technologies

Kevin Charleston
wrote on 5 April 2011
at 8:41 p.m.:

Brent, your advert says "deficiency" not "insufficiency". These are very different things.

As you point out - that review suggests scientific consensus of "deficiency" is 20ng/mL. This is a single review and not a study.

Note that the NIH fact sheet at http://ods.od.nih.gov/factsheets/vitamind indicates the deficiency level at 12ng/mL - and suggests that 12-20ng/mL is "Generally considered adequate for bone and overall health in healthy individuals". There is no indication that additional Vitamin D is required in people with co-morbidities you mentioned, but there are indications that deficiency can both aggravate, and be more likely in patients with other problems.

John Cannell and the rest of the "Vitamin D Council" may well have great knowledge in this area. The 2009 Tax statement shows he was paid $60k - and the 'council' received donations of over $100k - and the website proudly says they are sponsored by Vitamin D suppliers. Do you have anything with a truly independent opinion to back up a statement that >30ng/mL is sufficient?

Virtually everywhere else I look suggests things like this: "Levels above 30 ng/ml (75 nmol/L) are proposed by some as desirable for achieving optimum health, but there is not yet enough evidence to support this"

Firstly, use of the words “deficiency" or "insufficiency" is semantics. Different studies use the terms interchangeably. Most refer to deficiency. BOTH words mean deficiency and both are an insufficiency; yet, most importantly, neither are a “sufficiency”.

Some studies refer to “milder forms of deficiency” when referring to the “insufficiency” 15-32ng/ml range. The two words can be used interchangeably.

Secondly, there are many studies and reviews that support vitamin D blood levels of 33ng/ml or more at optimal (and safe), not for bone health (where lower levels are fine), but for soft tissue health, ie heart, immune system support, cancer risk-reduction (prevention) etc.

For example this meta analysis published in the March 2007 American Journal of Preventive Medicine:

Optimal Vitamin D Status for Colorectal Cancer Prevention

http://www.ajpm-online.net/article/S0749-3797(06)00498-3/abstract

“A 50% lower risk of colorectal cancer was associated with a serum 25(OH)D level ≥33 ng/mL, compared to ≤12 ng/mL.” and
“The evidence to date suggests that daily intake of 1000–2000 IU/day of vitamin D3 could reduce the incidence of colorectal with minimal risk.”

Regards

Brent

Brent Murphy – B.Pharm (Rhodes), MPS
Pharmacist
SOLAL Technologies

Kevin Charleston
wrote on 6 April 2011
at 7:25 a.m.:

Bret - funny that. Your post at 5 April 2011 5:01 p.m refers to a study that explicitly states separate categories for deficiency, insufficiency and sufficiency. It wasn't semantics then.

Do you have anything other than the single analysis? The abstract states nothing about deficiency - just that levels > 33ng/mL may present a 50% lower risk of colo-rectoral cancer.

What I am saying is that "insufficiency" is commonly referred to as "milder forms of deficiency", or simply "deficiency". Use of the word deficiency is therefore quite acceptable.

And, as I said, there are many studies. Here is one where from the Feb 2011 Journal of infectious diseases where insufficiency and deficiency are used as synonyms for levels of vitamin D below 30ng/ml:

Low vitamin D among HIV-infected adults: prevalence of and risk factors for low vitamin D Levels in a cohort of HIV-infected adults and comparison to prevalence among adults in the US general population:

"Similar to findings in US adults generally, vitamin D insufficiency or deficiency is highly prevalent among HIV-infected adults and is associated with known risk factors. Observed associations of vitamin D levels with renal insufficiency and with use of ritonavir- and efavirenz-containing regimens are consistent with both HIV-related and therapy-mediated alterations in vitamin D metabolism. Clinicians should consider screening all patients for vitamin D insufficiency or deficiency."

Regards

Brent

Kevin Charleston
wrote on 7 April 2011
at 7:38 a.m.:

Brent, at best the statement that "80% of South Africans tested at the integrative medical centre were deficient in vitamin D" is economical with the truth; and at worst it is an unsupportable distortion.

We can continue swapping URLs - but there is little point.

From what evidence you have been able to provide, you would have to change the statement to to read "80% of South Africans (already unwell with two or more of the following co-morbidities: osteoporosis, heart disease, hypertension, an autoimmune disease, cancer, depression, chronic fatigue or chronic pain) tested at the integrative medical centre would be considered deficient in vitamin D by some scientific studies, but not at the level which is currently the medically accepted level of deficiency".

As mentioned in my post at 5.01pm on 5 April, the 80% cutoff is based in a review here, with no co-morbidities!

The co-morbidities was the vitamin D council info.

Here is the review:

Benefits and requirements of vitamin D for optimal health: a review. Located here: http://www.ncbi.nlm.nih.gov/pubmed/15989379

Extracts:

“The current vitamin D requirements in the United States are based on protection against bone diseases. These guidelines are being revised upward in light of new findings, especially for soft-tissue health.”

“The consensus of scientific understanding appears to be that vitamin D deficiency is reached for serum 25-hydroxyvitamin D (25OHD) levels less than 20 ng/mL (50 nmol/L), insufficiency in the range from 20-32 ng/mL, and sufficiency in the range from 33-80 ng/mL, with normal in sunny countries 54-90 ng/mL, and excess greater than 100 ng/mL.”

Regards

Brent

Harris
wrote on 7 April 2011
at 3:10 p.m.:

The original claim stated: "90% of South Africans tested at the Integrative Medical Centre in Bryanston last year were deficient in vitamin D3, making it the most important vitamin for adults and children to take."

Brent can argue as much as he likes but cannot subvert the explicit messages that this statement makes.

Having evaluated Solal's lab results:

Solal's results cannot be extrapolated to children.

Individuals attending this clinic are not a representative sample of South African adults in general, akin to claiming that the vit D3 levels of individuals attending a sangoma in Pofadder can be extrapolated to claim, "making it the most important vitamin for adults and children to take."

Kevin Charleston
wrote on 7 April 2011
at 6:54 p.m.:

Brent - your words:

With regards to our statement that “90% of South Africans tested at the integrative medical centre were deficient in vitamin D”:
These were in patients with two or more of the following co-morbidities: osteoporosis, heart disease, hypertension, an autoimmune disease, cancer, depression, chronic fatigue or chronic pain.

Clearly you arent reading this thread (see 5 April 5.01pm post). As mentioned above, the 90% and comorbidity reference level we used as a cut off was 50ng/ml, based on recommendations from the vitamin D council, here: http://www.vitamindcouncil.org/vdds.shtml where they state:

“We propose Vitamin D Deficiency Syndrome (VDDS) exists when 25(OH)D levels of less than 50 ng/mL are found in patients with two or more of the following conditions: osteoporosis, heart disease, hypertension, autoimmune diseases, certain cancers, depression, chronic fatigue, or chronic pain.”

HOWEVER,
due to criticism of bias against the vitamin D council, in subsequent advertising (last year) we changed the “90%” to “80%”, since a review published in alternative medicine review in 2005 stated that vitamin D sufficiency can only be said to exist (in healthy people - NO COMORBIDITIES) when levels of vitamin D are 33ng or greater.

The data we supplied of people in Bryanston showed that 81.8% of people had below 33ng/ml of vitamin D.

See: Benefits and requirements of vitamin D for optimal health: a review. Located here: http://www.ncbi.nlm.nih.gov/pubmed/15989379

Extracts:

“The current vitamin D requirements in the United States are based on protection against bone diseases. These guidelines are being revised upward in light of new findings, especially for soft-tissue health.”

“The consensus of scientific understanding appears to be that vitamin D deficiency is reached for serum 25-hydroxyvitamin D (25OHD) levels less than 20 ng/mL (50 nmol/L), insufficiency in the range from 20-32 ng/mL, and sufficiency in the range from 33-80 ng/mL, with normal in sunny countries 54-90 ng/mL, and excess greater than 100 ng/mL.”

Regards

Brent

Brent Murphy - B.Pharm (Rhodes), MPS Pharmacist SOLAL Technologies

Harris
wrote on 7 April 2011
at 10:45 p.m.:

Hi Brent,

At issue here is how you determined what the correct cut-off levels for the various deficiency states are, i.e., is the levels generally accepted in credible scientific circles.

In support of your choice of values, the Vitamin D council values were first used but subsequently you used values suggested by an article you reference above. This article published in 2005 in the Alternative Medicine Review and was authored by the Sunlight Nutrition and Health Research Center, a Vitamin D council sponsored group. (http://www.sunarc.org/)

Since 2005, a great deal of advances have occurred as reflected in the January 2011 position statement of the Expert Consultation of the Office of Dietary Supplements (ODS) in the USA.

Although the levels recommended may have been controversial, there are important aspects related to values discussed in this document:

“Optimal serum concentrations of 25(OH)D for bone and general health have not been established; they are likely to vary at each stage of life, depending on the physiological measures selected [1,2,6]. Also, as stated earlier, while serum 25(OH)D functions as a biomarker of exposure to vitamin D (from sun, food, and dietary supplements), the extent to which such levels serve as a biomarker of effect (i.e., health outcomes) is not clearly established [1].”

And

“. . . the FNB committee that established DRIs for vitamin D extensively reviewed a long list of potential health relationships on which recommendations for vitamin D intake might be based [1]. These health relationships included resistance to chronic diseases (such as cancer and cardiovascular diseases), physiological parameters (such as immune response or levels of parathyroid hormone), and functional measures (such as skeletal health and physical performance and falls). With the exception of measures related to bone health, the health relationships examined were either not supported by adequate evidence to establish cause and effect, or the conflicting nature of the available evidence could not be used to link health benefits to particular levels of intake of vitamin D or serum measures of 25(OH)D with any level of confidence.”
http://ods.od.nih.gov/factsheets/vitamind/

The take home message appears to be that:

It is extremely difficult to determine what levels constitute “deficient” or otherwise.

It is not easy to measure Vit D levels

Vit D homeostasis and requirements are a complex affair.

“the extent to which such levels serve as a biomarker of effect (i.e., health outcomes) is not clearly established”

“health relationships examined were either not supported by adequate evidence to establish cause and effect”

These issues influence what constitutes a “deficient” or “normal” value and for and claims one may make.

The only reason I was harping on about the 2005 report is that Kevin kept asking for my rationale for the 32ng/ml deficiency/sufficiency cut-off I was using.

Please bear in mind that the Jan 2011 FNB (food and nutrition board) IOM (institute of medicine) recommendations came about more than 2 years after SOLAL’s initial vitamin D statements.

It is interesting to note that the FNB IOM raised the upper safe level of vitamin D from 2000IU to 4000IU. It also raised the recommended dietary allowance (ie the minimum requirements for health) to 600IU for people aged 1-69 years of age; and to 800IU for people over 70 years of age. This is greater than the schedule 3 dosage of >500IU (when vitamin D is used as a medicine) in South Africa (which needs to be descheduled asap).

However I do agree with you that the “normal” levels of vitamin D and what constitutes a deficiency is debateable.

Regarding vitamin D testing accuracy, we are not finding problems in that regard at our medical centre.

I also agree that vitamin D homeostasis is a complex affair.

I understand and accept that in some cases vitamin D is not necessarily a biomarker of effect. I am therefore happy to change the wording of our statements to say something like this:

Most human studies show that there is an association between having adequate vitamin D blood-levels and a reduced risk of some types of cancers. It remains unclear if this is only an association, or if vitamin D is actually responsible for this benefit, since there are no studies at present to show that vitamin D supplementation actually reduces the incidence of cancer in humans. There are some animal and human tissue studies which indicate that vitamin D does have anti-cancer properties and mechanisms. Based on the evidence available, SOLAL Technologies recommends a maximum of 2000IU of vitamin D daily.”

Brent - don't tell me what I clearly do or do not read. Communication is a two way street. Perhaps the fact is that you clearly can't communicate.

The adjacency of the sentences regarding "tested at" and "co-morbidities" which I highlighted clearly indicate to me that the blood tests, from which you presented the data, were from people who had two or more co-morbidities.

Are you actually saying these were completely healthy people selected at random?

And that you based the 90% on a deficiency level suggested by a mouthpiece of the vitamin companies?

And that you have now adjusted the figure down to 80% because of complaints of the source of that deficiency level?

Kevin Charleston
wrote on 8 April 2011
at 7:41 a.m.:

I'm puzzled by this. It appears that Vitamin D > 500IU is considered to be a schedule 3 substance by the SA Dept. of health? Should advertisements referring to values > 500IU even be allowed?

In terms of section 22A(5)(f) of the Act, a practitioner, nurse or a person registered under the Health Professions Act, 1974 (Act 56 of 1974) other than a medical practitioner or dentist may prescribe and supply, only within his/her scope of practice and subject to the indication for use of such substances
and medicines and to the conditions determined by the Medicines Control Council, to patients under his/her care, the Schedule 3 substances and Medicines provided for in the Annexures to this Schedule published in the Gazette in terms of the Act.

. . .

Vitamin D; preparations thereof for injection and oral preparations and mixtures thereof containing more than 500 I.U. per recommended daily dose, except when registered in terms of the provisions of the Fertilizers, Farm
Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).

There are many people out there who are absolutely desperate for some relief from their ailments. I was about to make a shopping list of all the Solal products that I would need, but decided to check them and their claims out, which led me here.
Who does one believe?